510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032091Substantially Equivalent

Smart Klamp Various by Size

Emergogroup, Inc., Clearwater FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032091 is the FDA 510(k) clearance record for SMART KLAMP VARIOUS BY SIZE, a class II device, cleared for Emergogroup, Inc. on under FDA product code HFX (Clamp, Circumcision). FDA records list 2 510(k) clearances for Emergogroup, Inc., from to . As of , FDA records show no recalls naming K032091.

Clearance record

Decision date
Received
(245 days to decision)
Product code
HFX Clamp, Circumcision
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Emergogroup, Inc. 2454 Mcmullen Booth Rd., Clearwater FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HFX

Trailing 12 months
1 clearance under product code HFX in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HFX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260